CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
Check against the official notice below — it lists the full affected range.
The Claravue Pre-wired Electrode IP-SET N3 Pediatric-US Model 32028776 50401-US is being recalled because it does not meet the electrical safety requirements specified in the ANSI/AAMI EC53:2013/(R)2020 standard for ECG trunk cables and patient leadwires. Specifically, the device fails to withstand a 5,000 V direct current application without breakdown when used with a defibrillator operating above its maximum threshold voltage. This failure means the device may deliver an inefficient electrical charge, potentially resulting in an ineffective defibrillation.
Approximately 40 units of this device were distributed nationwide across Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma, and Vermont. All lots are identified by UDI 03700506307357. The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.
Reason for recall: Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation. Distribution: US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT. Quantity: 40 units Lot/code info: All lots UDI: 03700506307357
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.